What is the mechanism of action of this treatment?

Common treatments for anovulation include clomiphene citrate, which blocks estrogen receptors in the brain to increase FSH and LH release, and gonadotropins, which directly stimulate the ovaries to produce follicles and induce ovulation. Lifestyle modifications can also help optimize hormonal balance. These treatments are crucial for anovulation patients as they enhance the chances of successful ovulation and pregnancy. While the trial focuses on sperm sorting techniques for male infertility, it underscores the importance of precise and targeted reproductive treatments.

What side effects are associated with this type of intervention?

Common treatments for anovulation include medications like Clomiphene Citrate, Letrozole, and Gonadotropins. Clomiphene Citrate can cause side effects such as hot flashes, bloating, breast tenderness, and mood swings. Letrozole may lead to fatigue, dizziness, and headaches. Gonadotropins, which are injectable hormones, can result in ovarian hyperstimulation syndrome (OHSS), multiple pregnancies, and injection site reactions. While Density Gradient Centrifugation and Microfluidic Sperm Sorting are primarily used for sperm preparation in assisted reproductive technologies, they do not directly treat anovulation and thus have different side effect profiles related to sperm quality and fertilization outcomes.

What prior FDA approvals exist?

FDA-approved treatments for anovulation primarily include medications that stimulate ovulation. Clomiphene citrate (Clomid) is one of the most commonly prescribed drugs, which works by stimulating the release of hormones necessary for ovulation. Letrozole (Femara), an aromatase inhibitor, is also used off-label for ovulation induction. Gonadotropins, such as human menopausal gonadotropin (hMG) and recombinant follicle-stimulating hormone (rFSH), are injectable medications that directly stimulate the ovaries to produce multiple follicles. These treatments are often used in conjunction with assisted reproductive technologies like intrauterine insemination (IUI) and in vitro fertilization (IVF).

What other types of research exist?

One promising novel alternative to Density Gradient Centrifugation and Microfluidic Sperm Sorting is the use of Magnetic-Activated Cell Sorting (MACS). MACS uses magnetic fields to separate sperm based on the presence of apoptotic markers, potentially improving sperm quality by selecting non-apoptotic, viable sperm. Another emerging technique is the use of electrophoretic sperm sorting, which separates sperm based on their charge and motility characteristics, potentially enhancing the selection of highly motile and morphologically normal sperm. Both methods are being explored for their potential to improve outcomes in assisted reproductive technologies.

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Sperm Preparation

Sperm Preparation Techniques for Infertility (PIoUS Trial)

N/A

Recruiting

Led By Mitchell Rosen, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient assigned female at birth with age <41

Be older than 18 years old

Must not have

Use of frozen donor sperm

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 treatment cycles, an average of 5 months

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two ways of preparing sperm for fertility treatment. One method spins the sperm to pick out the good ones, while the other uses a special device to sort them naturally. The study aims to see which method leads to better pregnancy outcomes for patients undergoing intrauterine insemination.

Who is the study for?

This trial is for individuals assigned female at birth, under the age of 41, who are undergoing intrauterine insemination due to anovulation or unexplained infertility. It's not suitable for those with significant diseases or psychiatric disorders that affect consent, users of frozen donor sperm, non-English speakers, or those with prior intrauterine inseminations.

What is being tested?

The study compares two methods of preparing sperm before intrauterine insemination: Zymot Multi (a microfluidic sorting device) and density gradient centrifugation. The goal is to see which method leads to better pregnancy outcomes in a randomized controlled setting.

What are the potential side effects?

Since this trial focuses on sperm preparation methods rather than medications, there are no direct side effects like you'd expect from drugs. However, general risks associated with intrauterine insemination may still apply.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a woman under 41 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am using frozen donor sperm for conception.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 treatment cycles, an average of 5 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 treatment cycles, an average of 5 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 treatment cycles, an average of 5 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cumulative clinical pregnancy rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Density gradient centrifugationActive Control1 Intervention

Patients will undergo sperm preparation by density gradient centrifugation

Group II: Zymot sperm separation deviceActive Control1 Intervention

Patients will undergo sperm preparation by the Zymot sperm separation device

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for anovulation include clomiphene citrate, which blocks estrogen receptors in the brain to increase FSH and LH release, and gonadotropins, which directly stimulate the ovaries to produce follicles and induce ovulation. Lifestyle modifications can also help optimize hormonal balance. These treatments are crucial for anovulation patients as they enhance the chances of successful ovulation and pregnancy. While the trial focuses on sperm sorting techniques for male infertility, it underscores the importance of precise and targeted reproductive treatments.

Relativity of the concept 'high responder to gonadotrophins'.Pharmacologic manipulation of fertility.The effect of androgen administration on in vitro fertilization outcome in poor responders undergoing ovarian stimulation with microdose protocol: A randomized clinical trial.